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CompletedNCT00057733Updated May 30, 2013

Stress Management Training in Patients Undergoing Radiation Therapy for Cancer

An interventional study of psychosocial assessment and care and quality-of-life assessment in Anxiety Disorder, Depression and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by University of South Florida. Completed at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-30.

Sponsored by University of South Florida · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Stress management techniques such as muscle relaxation, guided imagery, and abdominal breathing may improve quality of life and decrease emotional distress in patients who are undergoing radiation therapy for cancer.

PURPOSE: Randomized clinical trial to determine the effectiveness of stress management training in helping cancer patients cope with the emotional distress of radiation therapy.

Read the detailed description

OBJECTIVES:

Primary

  • Determine whether a modified version of a self-administered stress management training intervention, previously found to be of benefit in chemotherapy patients, is effective in improving quality of life and decreasing psychological distress (anxiety and depression) in patients with cancer who are undergoing radiotherapy.

Secondary

  • Compare the efficacy of this intervention on improving quality of life and decreasing psychological distress (anxiety and depression) in male vs female patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive self-administered stress management training (SSMT) in 3 stress management techniques (progressive muscle relaxation training and guided imagery, abdominal breathing, and coping skills) adapted specifically for use during radiotherapy. Patients initially receive a 5-minute standardized presentation regarding the nature and purpose of SSMT. Patients then receive information and instruction regarding the three stress management techniques comprising a videotape, audiotape, and brochure. Patients also receive their institution's usual psychosocial care.
  • Arm II: Patients receive their institution's usual psychosocial care only. Quality of life, anxiety, and depression are assessed at baseline and then at 1, 2, and 3 weeks. Intervention helpfulness is assessed at 3 weeks.

PROJECTED ACCRUAL: A total of 327 patients (approximately 163 per treatment arm) will be accrued for this study within 2 years.

02

Conditions studied

  • Anxiety Disorder
  • Depression
  • Unspecified Adult Solid Tumor, Protocol Specific

Keywords

  • anxiety disorder
  • depression
  • unspecified adult solid tumor, protocol specific
03

In context

Anxiety Disorders

5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.

Browse Anxiety Disorders studies →

Lead sponsor

University of South Florida is the lead sponsor of 338 studies on the registry; 63 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer
  • Must be scheduled to receive a minimum of 12 radiotherapy treatments over a 21-day period

    • Must not be scheduled to receive CNS irradiation
    • Must not be scheduled to receive radiotherapy as palliative care only
    • Prostate seed implants allowed

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Able to read and speak English

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 4 weeks since prior chemotherapy
  • No concurrent cytotoxic chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • No prior radiotherapy

Surgery

  • Not specified
05

Study design

Phase
Not applicable
Allocation
Randomized

Interventions

  • Procedurepsychosocial assessment and care
  • Procedurequality-of-life assessment
06

Study locations

12 sites
  • CCOP - Western Regional, Arizona
    Phoenix, Arizona 85006-2726, United States
  • CCOP - Bay Area Tumor Institute
    Oakland, California 94609-3305, United States
  • Howard University Cancer Center at Howard University Hospital
    Washington D.C., District of Columbia 20060, United States
  • MBCCOP - Howard University Cancer Center
    Washington D.C., District of Columbia 20060, United States
  • Comprehensive Cancer Care Center at Bethesda Memorial Hospital
    Boynton Beach, Florida 33435, United States
  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
    Tampa, Florida 33612-9497, United States
  • Cancer Care and Research Pavilion at St. Joseph's/Candler
    Savannah, Georgia 31405, United States
  • CCOP - Cancer Research for the Ozarks
    Springfield, Missouri 65807, United States
  • MBCCOP-Our Lady of Mercy Cancer Center
    The Bronx, New York 10466, United States
  • CCOP - Columbus
    Columbus, Ohio 43206, United States
  • CCOP - Scott and White Hospital
    Temple, Texas 76508, United States
  • CCOP - Northwest
    Tacoma, Washington 98405-0986, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00057733
First posted
Apr 9, 2003
Start date
Feb 2003
Primary completion
Apr 2005
Completion
Jun 2006
Last update
May 30, 2013

Study contacts

Paul Jacobsen, PhD
study chair · University of South Florida
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2005. You cannot join it, but the record below documents what was studied.

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